A Study of LY3493269 in Healthy Participants

A Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of an LY3493269 Formulation in Healthy Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3493269 in healthy participants. The blood tests will be performed to check how much LY3493269 gets into the bloodstream, how long the body takes to eliminate it and how body handles LY3493269. The study will last up to approximately 71 days for each participant, including screening

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: LY3493269; Drug: Salcaprozate Sodium

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 138623
    • Lilly Centre for Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Are male or female not of childbearing potential
2. Body mass index within the range of 19.0 to 40.0 kilograms per square meter (kg/m²) (inclusive)
3. Participants who are healthy as determined through medical evaluation including screening medical history, physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ECG)
4. Have clinical laboratory test results within normal reference range for the population or clinical research unit (CRU), or results with acceptable deviations that are judged to be not clinically significant by the investigator
5. Have venous access sufficient to allow blood sampling as per the protocol.

Exclusion Criteria:

1. Have a significant history of or current CV (for example, myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, renal, GI, endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk while taking the IP; or of interfering with the interpretation of data
2. Have undergone any form of bariatric surgery
3. Have a history of gastrointestinal (GI) bleeding or duodenal ulcers
4. Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
5. Have a history of acute or chronic pancreatitis, or elevation in serum lipase and/or amylase levels greater than 1.5 times the upper limit of normal (ULN)
6. Have clinical signs or symptoms of liver disease, acute or chronic hepatitis
7. Have evidence of significant active neuropsychiatric disease as determined by the investigator
8. Have been treated with prescription drugs that promote weight loss within 3 months prior to screening
9. Are currently enrolled in a clinical study involving an IP or any other type of medical research judged not to be scientifically or medically compatible with this study
10. Have participated within the past 30 days of screening in a clinical study involving an investigational product (IP); at least 5 half-lives or 30 days, whichever is longer, should have passed
11. Have an abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG (QT) data analysis, such as a QTcF greater than (>) 450 milliseconds (msec) for males and > 470 msec for females, short PR interval (< 120 msec), or PR interval > 220 msec, second and third atrioventricular block, intraventricular conduction delay with QRS >120 msec, right bundle branch block, left bundle branch block or Wolff-Parkinson-White syndrome
12. Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times (X) ULN or total bilirubin level (TBL) >1.5X ULN
13. Show evidence of HIV infection and/or positive human HIV antibodies
14. Show evidence of hepatitis C and/or positive hepatitis C antibody
15. Show evidence of hepatitis B, positive hepatitis B core antibody, and/or positive hepatitis B surface antigen
16. Have donated blood of more than 450 mL, or have participated in a clinical study that required similar blood volume drawn within the past 3 calendar months
17. Have known allergies to LY3493269, related compounds, or any components of the formulation (including SNAC), or a history of significant atopy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants received placebo orally once daily (QD) for three consecutive days.	Drug: Placebo; Administered orally.
Experimental: 8 Milligrams (mg) LY3493269 + 600 mg Salcaprozate Sodium (SNAC); Participants received 8 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.	Drug: LY3493269; Administered orally.; Drug: Salcaprozate Sodium; Administered orally.
Experimental: 24 mg LY3493269 + 600 mg SNAC; Participants received 24 mg LY3493269 and 600 mg SNAC QD administered orally for three consecutive days.	Drug: LY3493269; Administered orally.; Drug: Salcaprozate Sodium; Administered orally.
Experimental: 12 mg LY3493269 + 300 mg SNAC; Participants received 12 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.	Drug: LY3493269; Administered orally.; Drug: Salcaprozate Sodium; Administered orally.
Experimental: 4 mg LY3493269 + 300 mg SNAC; Participants received 4 mg LY3493269 and 300 mg SNAC QD administered orally for three consecutive days.	Drug: LY3493269; Administered orally.; Drug: Salcaprozate Sodium; Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs)	TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. A summary of serious adverse events (SAEs), TEAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Adverse Events section of this record.	Baseline through Day 44

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours (AUC [0-24]) of LY3493269	PK: AUC (0-24) of LY3493269	Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post dose
PK: Maximum Concentration (Cmax) of LY3493269	PK: Cmax of LY3493269	Day 3: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, & 24 hours post dose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Actual): November 11, 2021
• Study Completion (Actual): November 11, 2021

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 17552; J1X-MC-GZHF (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes